Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
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Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
4actual
Sites
56
Countries
Japan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Study was terminated by Sponsor; the decision was not due to any safety findings.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-05 | actual | When the study began enrolling |
| Primary completion | 2025-04-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-16 | actual | The whole study's end, after follow-up |
| First posted | 2025-01-20 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-08 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- RSV Infection
Interventions
- Drug: Obeldesivir — also filed as ODV, GS-5245
- Drug: Obeldesivir Placebo
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28
measured Up to Day 28
Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28
measured Up to Day 28
Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28
measured Up to Day 28
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-09-27 · 3.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-11-17 · 2.1 MB · SAP_001.pdf
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